FROM THE EDITOR

A recent survey by the American Gastroenterologist Association (AGA) reveals that while biosimilar manufacturers are still battling challenges in order to bring these drugs to market, at least some members of the medical community will welcome them with open arms once they’re available.

The current standard monoclonal antibody purification process is typically composed of three column steps – protein A chromatography, then cation exchange chromatography, followed by anion exchange chromatography or multimodal chromatography.

BIOPROCESS CONTRIBUTING EDITORS

After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed.

The Boston Globe recently published an article revisiting the industry’s ongoing struggle to determine a labeling system for biosimilars— a challenge that reflects the industry’s insecurity over what seems to be an increasingly destabilizing generics environment.

Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.

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ProVance™ Protein A Columns are a portfolio of single campaign-use columns designed for GMP purification of monoclonal antibodies. Prepacked with Grace® Protein A resin and available in a range of sizes, these columns expedite purification steps and help improve overall downstream productivity. The columns come complete with a regulatory support file and since they are disposable, eliminate the need for tedious clean in place and column packing procedures. ProVance™ columns can give you a competitive advantage by reducing non-value added labor steps and allowing focus on more important downstream processing tasks.

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